Clinical Diagnosis of Acute Appendicitis with Normal WBCS... | NCT06834958

Studies
Clinical Diagnosis of Acute Appendicitis with Normal WBCS Count with Role of Inflammatory Markers and Radiology

NCT06834958

Sponsor

Assiut University

Status

Active, not recruiting

Last Update Posted

Feb 19, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Acute Appendicitis

Interventions

Appendectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Oct 1, 2027Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Jan 31, 2025

First Submission Date that Met QC Criteria

Feb 14, 2025

First Posted Date

Feb 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2025

Last Update Posted Date

Feb 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to describe the proportion of pa-tients with normal preoperative inflammatorymarkers among patients with histopathologically proven acute appendicitis

Detailed Description

2.4.1- Type of the study: prospective clinical trial study 2.4. 2- Study Setting: Assuit university hospital 2.4. 3- Study subjects:

Inclusion criteria:

patients complain of Rt iliac pain with Us positive for acute appendicitis with WBCS normal .
Exclusion criteria:

malignant mass cancer appendix mesenteric adentis cecal diverticulum salpingitis c. Sample Size Calculation: 50 cases 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Lab WBCS count CRP level Neutrophil differential count Clinical correlation US findings and MSCT if needed

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient included who have acute appendicitis clinically and normal WBCS count			Procedure: Appendectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Appendectomy	Procedure	Open surgery for appendix which is inflamed	Patient included who have acute appendicitis clinically and normal WBCS count

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgery done if needed	Patient with acute appendicitis and normal WBCS count will be under observation for while but people with evidence on imaging and high inflammatory markers will go under surgery	Days of hospital reservation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion

Male or female patients é clinically diagnosed acute appendicitis with normal WBCS

Exclusion Criteria:

complicated AA (perforation, peri appendicular abscess or suspicion of a tumor.

2_inflammatory bowel diseases 3_inability to co-operate and give informed consent 4_diffuse peritonitis 5_Patients with serious comorbid conditions DM & renal insufficiency, serum creatinine > 150 μmol/l 6_Pregnant & lactating patient 7_Patients with advanced malignancies & pt on immunosuppressive drugs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Days

Maximum Age

60 Days

Standard Ages

Child

Study Population

Study not need special type of people

Sampling Method

Non-Probability Sample

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001062	Appendectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided